The present invention generally relates to objective characterization methods for female pelvic tissues. Specifically, the invention describes methods for characterizing vaginal tissue elasticity and detection of a pelvic organ abnormality. For the purposes of this description, the terms “pelvic organ abnormality”, “pelvic floor abnormality” and “vaginal abnormality” are used interchangeably.
Various stages of pelvic organ abnormality including a pelvic organ prolapse (POP) are highly prevalent affecting at least 50% of women in the US during their lifetimes. Some loss of utero-vaginal support occurs in most adult women. POP is the extreme case of descent of the apex of the vagina or cervix (or vaginal vault after hysterectomy), anterior vaginal wall, and/or posterior vaginal wall. As abnormality progresses, pelvic organs can become displaced and even protrude outside the vaginal canal. POP is the leading indication for hysterectomy in postmenopausal women and accounts for 15-18% of procedures in all age-groups [Kesharvarz H, Hillis S D, Kieke B A, Marchbanks P A. Hysterectomy surveillance—United States 1994-1999. MMWR Surveill Summ 2002; 51 (5505):1-8]. Beyond the physical impact of POP, women with progressing pelvic organ abnormality score poorer on both generic and condition specific quality-of-life scales [Jelovsek J E, Barber M D. Women seeking treatment for advanced pelvic organ abnormality have decreased body image and quality of life. Am J Obstet Gynecol. 2006; 194: 1455-61.]. In addition, about one third of sexually active women with POP report that their condition interferes with sexual function [Barber M D, Visco A G, Wyman, et al. Sexual function in women with urinary incontinence and pelvic organ abnormality. Obstet Gynecol. 2002; 99:281-9.].
Clinical diagnosis of vaginal abnormalities and ultimately POP involves taking a medical history and performing a manual physical examination when a physician inspects the urogenital areas and rectum for masses and indication of reduced muscle tone. The physician instructs the patient to cough, bear down or perform a Valsalva maneuver (a forceful attempt at exhalation with the mouth and nose closed) to see if and how far the vagina descends as the result of the additional abdominal pressure [Shagam J Y. Pelvic organ prolapse. Radiol Technol. 2006; 77(5):389-400].
While physical examination helps the clinician describe the extent of pelvic floor prolapse, it does not help in discerning the initial stage of abnormality development from the normal condition. Digital palpation does not provide quantitative tissue characterization to compare with normal elasticity of vaginal walls. It has poor sensitivity and is highly subjective.
Changes in the elasticity of the vaginal walls, connective support tissues, and muscles are significant factors in the development of POP. The high incidence of POP dictates the need for new effective methods of objective vaginal tissue characterization and early abnormality detection.